Mike on Medtech: Real World Evidence

Mike on Medtech: Real World Evidence

Mike Drues of Vascular Sciences offers insights into the use of real world evidence in medtech regulatory approval processes.

By Sean Fenske, Editor02.24.17
The use of real world evidence in the medical device approval process has gained much attention lately due to several reasons. It was specifically mentioned in the 21st Century Cures Act and it was also the topic of a recently released FDA Guidance document (PDF). As such, MPO reached out to our regulatory “go-to” guy, Mike Drues of Vascular Sciences, to gain some additional insights on what real world evidence actually is, why it matters to medical device manufacturers, and how they might be able to make efficient use of it.
Listen to the podcast streaming via the player below or you can download the MP3 file, load it onto your player of choice, and listen at your convenience.

Once you’ve had a chance to listen to the podcast, if you have any additional questions about real world evidence as it relates to medical device manufacturers, or you have a suggestion for a topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

Click here to review other episodes of Mike on Medtech.
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